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The “high-risk” patient

A "high risk" patient with legal addictions to junk food and tobacco.
She would be an excellent candidate for a trial of a drug to "treat" the symptoms, like "cholesterol", of a self-destructive lifestyle. Such people are beloved of drug dealers and trialist doctors on their payrolls because they are "high risk" and have high rates of "events" (i.e. artery bypass, heart attack and death) allowing investigators to publish papers faster and drug dealers to sell more drugs. Thus, all testing of drugs for lifestyle diseases necessitates conflict of interest. To insist that such people change their habits first would reduce "events", most of which are non-fatal, and prolong trials for so long that the high-paid "trialists" would die of old age before enough "events" had been registered to be statistcally significant. So NO trial of drugs for diseases of lifestyle has ever made a serious attempt to change lifestyles before trying drugs. All such trials were and are, therefore, UNETHICAL. Reports of the results of such trials should be retracted by the journals involved and the results should be ignored by all doctors. All such ongoing trials should be halted immediately.

Posts Tagged ‘atherosclerosis’

Not a surprising finding, Dr. Yusuf. Fifteen years ago Dean Ornish proved that atherosclerosis, the underlying cause of heart attacks, could be reversed with a version of the prudent diet. So why isn`t everyone doing this? Maybe because the cholesterol myth promoted by drug dealers and doctors on their payrolls convinced the population that all they had to do was take a pill to lower blood cholesterol and they could eat anything. Curiously, there is no mention of cholesterol in the story. Close reading of the paper published in Circulation reveals that there was no correlation between the diet and blood cholesterol, “bad” of “good”. Diet has a powerful effect on atherosclerosis independent of blood cholesterol. Probably something about the prudent diet reduces modification of LDL, so called “bad” cholesterol, in the arterial wall. Another body blow to the cholesterol myth which is slowly dying. Even Pfizer which has spend many $billions promoting the myth has given up on it.

SHARON KIRKEY CANWEST NEWS SERVICE
The Gazette
21 Oct 2008

Hold the fries, samosas or fried won tons: People who eat diets high in fried foods and meat are 35 per cent more likely than ?prudent? eaters to suffer acute heart attacks, a global study led by Canadian researchers shows. And in a surprising…read more…

A Russian hockey league is blamed for 19 year old Alexei Cherepanov’s death from atherosclerosis, proven by autopsy. Since when has hockey playing been a risk factor for atherosclerosis? There are two causes: tobacco and an atherogenic diet. I assume he didn’t smoke.

The league is blamed for not detecting it sooner. How would they have detected it? How do you predict atherosclerotic plaque rupture? If there is no plaque there is nothing to rupture. Plaque can be prevented and regressed by lifestyle alone. Did the coach ask him about his lifestyle, what he ate?

Out of their league?BY MATTHEW COUTTS National Post, with files from news services
National Post
16 Oct 2008

The shift just before 19-year-old elite hockey prospect Alexei Cherepanov collapsed and died during a game in Russia’s Continental Hockey League exemplified exactly what the league’s founders had in mind when they created an entity to rival North…read more…

Below is a example of the issues involved in treating chronic coronary atherosclerosis presented by an intelligent patient who asked questions about treatment and did not accept the mainstream opinion without good evidence.

The vast majority of patients with chronic coronary artery atherosclerosis can be treated as the patient described here. Most cardiologists still believe the profitable myth that heart attacks can be prevented by “treating” those blockages seen on a coronary angiogram. We now have good evidence that such blockages are composed of older, harder plaques that are less likely to rupture and cause a sudden total blockage and a heart attack. Angioplasty, stent or not, and coronary bypass are PALLIATIVE procedures indicated only for intractable symptoms related to decreased coronary blood flow reserve.

In the late 1960s, Professor G. S. H. Lock was engaged in the development of the artificial heart to address cardiac conditions for which other alternatives were not available. Forty years later he writes, “Today it is difficult to argue that technological intervention on such a scale is really necessary on a routine basis. Even intervention through angioplasty and the insertion of a stent may offer little more than temporary relief.”

In this article, adapted from a longer feature in The Lown Forum, Professor Lock shares his experiences as a cardiac patient and his observations on the use of medical technology in cardiovascular care. The Lown Forum is a publication of the Lown Cardiovascular Research Foundation; ProCor is one of its programs.

G.S.H. Lock, Professor Emeritus and former Dean of Interdisciplinary Studies, University of Alberta, Edmonton, Alberta, Canada

My story begins, as it often does, with the onset of mysterious chest pains. My family physician immediately diagnosed it as angina, meriting further investigation. After numerous tests on treadmills and in machines whose operations are still a mystery to me, I was confirmed as a high-risk patient with a plumbing problem, usually described as coronary arterial occlusion. An angiogram was recommended and scheduled within two weeks. However, this seemingly routine procedure created a special problem for me because three of my colleagues had failed to recover from that very procedure. With apprehension, I listened to the consulting physician explain that the risk of complication was minimal (about 1%). I asked if there was an alternative. I shall never forget his answer: “Death.”

Needless to say, I was not reassured by this response from a very able doctor who was obviously bound by prescribed procedure. Even though he was careful enough to prescribe appropriate medication while I waited for the angiogram procedure, I sought a second opinion, at another hospital. This proved to be an equal waste of time. The physician simply described the use of angiography as a “no brainer” because he viewed it as the natural prelude to intervention. No other possibility was even considered.

These experiences led me to conduct my own extensive research on heart disease, its diagnosis, and treatment. The majority of cardiologists seem to favor intervention, with all of the technology that accompanies, if not drives, it. I, however, could not support such an approach except in emergencies or when surgery was clearly the only means by which a patient’s life could be improved if not saved. Through the Lown Cardiovascular Center I was able to confirm that a healthy minority of cardiologists are not interventionists, but believe instead that in the majority of cases, heart disease may be treated more effectively using medical therapy with its four components: diet, exercise, lifestyle, and medication.

At first glance, I thought that each of these would prove to be distasteful – something that would destroy the quality of life – but I found instead the very opposite.

Luckily for me, my wife is an excellent cook – dare I say chef? – and has developed the standard Mediterranean diet into such a variety of dishes that I eat better now than I did two years ago. This alone took my cholesterol level down well below the established safe limit.

Exercise, too, has improved my quality of life. My cardiologist at the Lown Center, Dr. Vinch, is himself and athlete and he reminded me that the heart is a muscle that needs to be nourished and exercised like any other muscle. Under his guidance, I began various walking exercises. At first, using a nitroglycerine spray to decrease the resistance of the peripheral vascular system, I took my daily walks in the river valley where I live. Gradually, the walks became longer and steeper. Today, I can briskly walk up and out of the river valley and then jog up 12 flights of stairs without any angina, and without using the nitroglycerine.

If Michael Phelps’s diet is really as reported and he continues to eat like this, his risk of atherosclerosis and probably some cancers are elevated. While no detailed nutrient breakdowns are available, one can infer that a large fraction of his calories are coming from saturated fat and refined carbohydrate, nutrient poor calories. The “energy drinks” are liquid candy. He consumes few vegetables and no fruit. His intake is low in fiber, and could be low or borderline in other nutrients. While such a diet may rapidly supply the calories he needs for Olympic gold medals, in the long run his health will suffer. If he thinks he can eat chocolate chip pancakes as long as he exercises enough, he is dead wrong. And what kind of example does he set for the children of the USA and the world? “Hey Mom, I can eat chocolate chip pancakes instead of broccoli, just like Michael Phelps.”

REACH is an an acronym for REduction of Atherothrombosis for Continued Health. The term “atherothrombosis” was concocted by “industry” to market Plavix and has now infiltrated into the literature. This is a classic example of marketers inventing a disease for which their drug is the cure. The first and most lucrative was the invention of the disease,”dyslipidemia”, to market statins.

The web site, http://www.atherothrombosis.org, is funded by sanofi-aventis and Bristol-Myers Squibb who sell Plavix. Dr. Bhatt, an author of REACH, is prominent on the site. Here is a quote from the site by a Dr. Cannon:
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Atherothrombosis vs atherosclerosis: Different diseases?

The patients were divided into those who had had a prior event versus those who had not. Interestingly, the patients who’d had a prior event each had about a 20% reduction in death, MI, stroke over the subsequent 2 ½ years in this otherwise pretty stable outpatient population. On the other hand, there was no benefit whatsoever in those who had coronary disease without a prior MI, or cerebrovasculardisease without prior stroke. So, in thinking about this, the question comes up: ‘Does this mean that the patients with a prior event are different?’ They’ve had a thrombotic event as part of their course of vascular disease. The question popped into my head: ‘Would this mean, potentially, that atherothrombosis might be a different disease than atherosclerosis?’

If we circle back to thinking clinically, there are a lot of patients we see who are 80 years old who finally come in with evidence of angina and have diffuse atherosclerotic disease, but who have never had an MI or stroke; then there are other patients who come in at age 40 with a large anterior MI and just one atherosclerotic lesion on their cath. Those would seem to be two extremes: the atherosclerotic patient (the 80-year-old with diffuse disease) and the atherothrombotic patient (the person who comes in with an acute event). And, the difference in the benefit of dual antiplatelet therapy for the atherothrombotic patient makes perfect sense: you’re treating a thrombotic disease with an antithrombotic agent. This may give us insight into subcategorizing a little bit the disease process itself and targeting long-term therapies.
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Readers should be made aware of the disclosure of Dr. McDermott, the editorialist:
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Financial Disclosures: Dr McDermott reports that she has received honoraria from Bristol-Myers Squibb, Sanofi-Aventis, NicOx, and Otsuka Pharmaceutical, has served as a consultant for Hutchinson Technology, and is currently receiving support from research grants from the National Heart, Lung, and Blood Institute.
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Why couldn’t JAMA find an editorialist with no connection to “industry”, particularly the company funding the study which was editorialized?

If you wonder why this is a “free” publication just look at the disclosures and funding:
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Financial Disclosures: Dr Bhatt reports that he has received honoraria for consulting on scientific advisory boards from AstraZeneca, Bristol-Myers Squibb, Centocor, Eisai, Eli Lilly, GlaxoSmithKline, Millennium, Otsuka, Paringenix, PDL, Sanofi-Aventis, Schering Plough, The Medicines Company; honoraria for lectures from Bristol-Myers Squibb, Sanofi-Aventis, and The Medicines Company; and provided expert testimony regarding clopidogrel (the compensation was donated to a nonprofit organization). Dr Röther reports that he has received honoraria from Bristol-Myers Squibb and Sanofi-Aventis. Dr Steg reports that he has received honoraria from Bristol-Myers Squibb and Sanofi-Aventis and has received research grants from Sanofi-Aventis. Dr Steg reports having served as a member of the speakers’ bureau for Boehringer Ingelheim, Servier, GlaxoSmithKline, Merck, Sharp & Dohme, and Nycomed and also on a consultant ad board for AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Sharp & Dohme, Sanofi-Aventis, Servier, and Takeda. Dr Ohman reports that he has received research grants from Berlex, Sanofi-Aventis, Schering-Plough, Eli Lilly, Bristol-Myers Squibb, and Millennium. Dr Ohman reports that he has stock ownership in Medtronic, Savacor, and Response Biomedical and is a consultant for Invoise, Response Biomedical, Savacor, and Liposcience. Dr Hirsch reports that he has received research grants from Bristol-Myers Squibb and Sanofi-Aventis; honoraria from Sanofi-Aventis; and speaker’s bureau fees for Sanofi-Aventis. Dr Wilson reports that he has received a grant from Sanofi-Aventis. None of the other authors reported disclosures.

Funding/Support: The REACH Registry is sponsored by Sanofi-Aventis, Bristol-Myers Squibb, and the Waksman Foundation (Tokyo, Japan), who assisted with the design and conduct of the study and data collection.
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Call me paranoid but I have a suspicion that the conclusion of the next paper from REACH will be that “dual anti-platelet” therapy (read ASA and Plavix) is underused. Thus the “reduction” in REACH.

But the sponsors may have shot themselves in their feet. The REACH data shows that in Japan the use of statins is about two-thirds and hypertensives one-half of the world average but Japanese all-cause mortality is 40% less than the world average. Also the Japanese used about the same “dual anti-platelet therapy” as the world average. So, total mortality has no relation to drug use of all types. This glaring paradox is nowhere mentioned in the paper or the editorial and I doubt most readers will look at the data themselves.

In the final analysis, what is the point in studying atherosclerosis in a population in which 80% are overweight or obese, 44% are diabetic, 82% are hypertensive and 16% are smoking? The causes of their atherosclerosis are obvious, food and/or tobacco addictions as we have known for many years.

If sanofi-aventis and Bristol-Myers Squibb really want to reduce “atherothrombosis” and improve health they should fund programs for fighting these addictions instead of doing more surveys to try to justify more drug sales. From their own data it is clear that drugs do not increase life expectancy.

Personally, I refuse to take any advice from anyone who receives even one cent from a drug dealer.

I completely agree with Dr Kishore’s statement:

“Increasingly, ‘Western’ high-fat diets, tobacco use and urbanization have
helped make heart disease a bigger killer than ‘The Big Three’—HIV/AIDS,
tuberculosis and malaria—combined.”

Indeed, high risk individuals have high risk lifestyles.

But the FIRST thing to do is change the diet and eliminate tobacco BEFORE labeling statins essential drugs. To do otherwise will reduce any incentive to improve lifestyle and make the obesity and diabetes pandemic even worse.

Do you think that the “developing” world is going to be happy with generic simvastatin? Not likely. They are going to start demanding patented Crestor and Vytorin, just like the rich Americans.

Weill Cornell Medical College Students Help Change Global Health Policy

NEW YORK (May 21, 2007) – In a move to improve global public health, Weill
Cornell Medical College students have helped place a lifesaving heart
disease drug onto the World Health Organization’s (WHO) list of essential
medicines. This list is a guideline for developing countries to choose which
high-priority drugs should be supplied to their citizens inexpensively.

Students from Weill Cornell’s chapter of Universities Allied for Essential
Medicines (UAEM) answered the charge of Dr. David Skorton, President of
Cornell University, and Dr. Antonio M. Gotto Jr., dean of Weill Cornell
Medical College, to “seek new strategies for Cornell to advance public
health” across the globe.

“I am extremely proud that the students at Weill Cornell Medical College
have had such an admirable influence on global health policy,” says Dr.
Skorton, who is also a professor of internal medicine and pediatrics. “Such
actions by our students show the promise of their future leadership.”

“Adding this medicine to the list of essential medicines represents an
exceptional achievement by our students,” says Dr. Gotto, an internationally
renowned expert in heart disease prevention, who served as the senior
advisor for the project. “Because of the students’ success, over 150
national governments that work with WHO will be encouraged to recognize
heart disease as a serious health concern deserving of great medical
attention.”

UAEM comprises a national group of students whose goal is to determine how
universities can help ensure that biomedical products, including medicines,
are made more accessible in poor countries and further the amount of
research conducted on neglected diseases affecting the poor.

“For years, it was thought that heart disease was a concern of affluent
countries. But, today, nearly 80 percent of all deaths due to heart disease
occur in the developing world,” says Sandeep Kishore, an MD-PhD student at
Weill Cornell Medical College who helped spearhead the initiative with UAEM.
“Increasingly, ‘Western’ high-fat diets, tobacco use and urbanization have
helped make heart disease a bigger killer than ‘The Big Three’—HIV/AIDS,
tuberculosis and malaria—combined.”

Kishore and Ben Herbstman, UAEM members, petitioned WHO that simvastatin
(Zocor)—originally manufactured by Merck—be added to the list. Simvastatin
was selected based on its worldwide availability, cost-effectiveness and the
interest of generic firms in producing it. Such statin medicines have been
shown to lower low-density lipoprotein cholesterol (LDL) levels, commonly
known as “bad cholesterol,” by 25-30 percent in individuals at high-risk for
heart disease.

Last month, the students from UAEM — with the assistance of medical
librarians from Weill Cornell’s Samuel J. Wood Library & C.V. Starr
Biomedical Information Center — were successful in their efforts to get a
generic version of Zocor included on the list of essential medicines. Now,
the United Nations and other philanthropic foundations can donate large
numbers of the statin drug to the national pharmaceutical inventories of
developing countries.

Furthermore, generic versions of the medicine will be sold at a fraction of
their original price tag. The drug will cost as little as $40 per year per
person—10 cents a day—down from nearly $1,200 a couple of years ago.

The announcement comes on the heels of Cornell University’s new Africa
Initiative, a university-wide movement to promote sub-Saharan African
development and health.
The Weill Cornell chapter of UAEM has hosted an ongoing series of global
health events. On June 15, the former CEO of Merck, Inc., Dr. Roy Vagelos,
will present a lecture titled “Corporations Can and Should Do Social Good”
in a seminar exploring new academic-pharmaceutical alliances to increase
access to medicines worldwide.
Weill Cornell Medical College

Weill Cornell Medical College—located in New York City—is committed to
excellence in research, teaching, patient care and the advancement of the
art and science of medicine. Weill Cornell, which is a principal academic
affiliate of NewYork-Presbyterian Hospital, offers an innovative curriculum
that integrates the teaching of basic and clinical sciences, problem-based
learning, office-based preceptorships, and primary care and doctoring
courses. Physicians and scientists of Weill Cornell Medical College are
engaged in cutting-edge research in such areas as stem cells, genetics and
gene therapy, geriatrics, neuroscience, structural biology, cardiovascular
medicine, AIDS, obesity, cancer and psychiatry—and continue to delve ever
deeper into the molecular basis of disease in an effort to unlock the
mysteries behind the human body and the malfunctions that result in serious
medical disorders. Weill Cornell Medical College is the birthplace of many
medical advances—from the development of the Pap test for cervical cancer to
the synthesis of penicillin, the first successful embryo-biopsy pregnancy
and birth in the U.S., and most recently, the world’s first clinical trial
for gene therapy for Parkinson’s disease. Weill Cornell’s Physician
Organization includes 650 clinical faculty, who provide the highest quality
of care to their patients. For more information, visit http://www.med.cornell.edu.

Intravascular ultrasound is a sensitive method for measuring the size of atherosclerotic plaques in the arterial wall. When testing a drug to see if it will have an effect on plaque volume, this technique is the gold standard.

ILLUSTRATE set out to show that adding torcetrapib, a drug that increases HDL, the “good” cholesterol, to Lipitor, that decreases, LDL, “bad” cholesterol would reverse plaque or at least stop its progression.

Here are the baseline characteristics of the subjects. Note that the average BMI was 30. Overweight is defined as a BMI over 25 and obesity over 30. So, all of them were overweight or obese. 20% were diabetic, most likely Type 2, related to obesity, and 75% were hypertensive. 18% smoked. All of those factors are risk factors for atherosclerosis related to lifestyle. Therefore, unless one intends to first completely eliminate these lifestyle risk factors, it was unethical to even conceive such a trial particularly since it is proven that atherosclerosis can be reversed by lifestyle change alone. The trialists probably rationalized that atherosclerosis, like pneumonia, must be treatable by drugs and Pfizer, who funded the trial, has a slogan, “Working for a Healthier World” it is ethical to do such a trial. Besides the money helps to keep one’s IVUS lab going and one is promoting the notion that the technique will some day lead to the cure for atherosclerosis.

The typical ILLUSTRATE patient

Here are the reported results. What was not mentioned in the abstract above is that plaque actually INCREASED in both the the Lipitor only group and the Lipitor plus torcetrapib group. Now, before actually starting the trial, the subjects were given enough Lipitor to adhere to the guidelines written by doctors paid by Pfizer and other statin dealers. So, following the guidelines for blood cholesterol lowering with Lipitor does not slow progression of plaque. The obsession with blood cholesterol is completely futile.

nejm-illustrate-result.jpg

The conclusions of the authors shows their blinkered view of atherosclerosis. While Dr. Nissen donates his personal drug money to charity (how much is paid to run his IVUS lab, if any, is not stated), all the other authors have major financial connections to drug dealers. Revkin, Shear and Duggan are employees of Pfizer and own stock. Naturally this group would ignore non-drug methods for reversing atherosclerosis

We have known how to reverse the atherosclerotic process very easily since the revolutionary work of Dean Ornish the final report of which was published in 1998. No drugs are necessary, only a change in lifestyle which was not seriously attempted in this study. There is even no reference to Ornish’s work in the paper, a major oversight of the reviewers. So, why don’t the IVUS groups do a study of plaque volume after significant lifestyle change? Who would fund it? If Pfizer is really “Working for a Healthier World” and not just making a profit, Pfizer should be funding an IVUS lifestyle trial.

For 30 years since the development of a balloon-tipped catheter to dilate coronary arteries, now known as PCI (percutaneous coronary intervention), it has been revealed truth from “experts”, most of whom paid their mortgages by doing PCI’s, that all significant coronary narrowings should be dilated to prevent a heart attack. In spite of overwhelming evidence that heart attacks are caused by rupture or early, unstable, non-obstructive plaques, most cardiologists still believe that heart attacks (sudden complete blockage of a coronary artery) occur at the site of the largest plaques. Patients are shown angiograms and told they have a “widow maker” or are “sitting on a time bomb”. I refused to do angioplasties until there was some proof for this superficial but very lucrative theory. Again, it turns out I was right. Even in patients with major narrowings and symptoms, PCI does not prolong life or prevent heart attacks. Chronic symptoms were slightly more improved in the PCI group but most medically-treated patients had symptom improvement just with pills.

The COURAGE type subject

All cardiologists give lip service to the necessity for lifestyle change as the ultimate cure for atherosclerosis, but in this study there was no attempt at lifestyle change. Most patients were overweight or obese, gained weight over the five year study. 20% smoked and did not stop. While the authors claim to using “optimal” medical therapy, they did not even try significantly changing lifestyle, the obvious cause of the patients’ atherosclerosis. No doubt even better results that could have been obtained with just lifestyle change, without pills or PCI, as Dean Ornish showed many years ago.

If you want an explanation for why, except for a feeble attempt to raise HDL by exercise, NO attempt was made to change lifestyle meaningfully before using statins or PCI you need look no further than the source of funding and the disclosure statements of the authors. Those who recieve substantial income from drug dealers are not keen on proving that cost-free lifestyle change alone will do the same or better than expensive drugs.

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Now, why has it taken 30 years to finally prove the futility of PCI in patients with stable or stabilized coronary disease? Unlike new drugs, there are no rules and no government agency mandating that surgical procedures have to undergo clinical trials before being done on the general population. Any surgeon can develop some operation that seems superfically rational and he and his colleagues can do many thousands of those operations, costing millions or billions of dollars and risking many lives until someone gets around to actually testing it to see if the outcome is really as advertised.

Doctors profess to want to practice “evidence-based medicine” but when change negatively affects bank accounts habits change very slowly if at all. Angioplasty in stable CAD can always be rationalized by the classic, “my patient is different than those in the controlled trial”. We can predict that angioplasties in patients with stable CAD will not decline significantly until most of those trained in the procedure have retired. The system could save a lot of money by giving each of them $one million and a house in Mexico to retire to.